Drug Type Biosimilar, Colony-stimulating factors |
Synonyms Epoetin alfa, NeuroEPO, NeuroEPO (nasal) + [3] |
Target |
Mechanism EPO receptor agonists(Erythropoietin receptor agonists) |
Therapeutic Areas |
Active Indication |
Inactive Indication- |
Originator Organization |
Active Organization |
Inactive Organization- |
Drug Highest PhaseApproved |
First Approval Date CU (01 Apr 1998), |
Regulation- |
Indication | Country/Location | Organization | Date |
---|---|---|---|
Anemia, Aplastic | CU | 01 Apr 1998 |
Not Applicable | - | (tbkbgycond) = eefjzcopsb xwbkmyzztn (jfovowxyfo, 108.3 - NE) | Positive | 09 Dec 2023 | |||
(tbkbgycond) = qboxgaoqms xwbkmyzztn (jfovowxyfo, 5.9 - 157.3) | |||||||
Not Applicable | 174 | - | Positive | 31 Dec 2021 | |||
Phase 3 | - | qgwmixscdx(aneibuqgfp): 0.73 (95% CI, 0.58 - 0.94), P-Value = 0.013 | Positive | 19 Oct 2020 | |||
Not Applicable | 3,890 | fdbwfydpiy(horjdknroh) = lyxdxruvhu rnczzsbsic (serxkbkvxe ) View more | Positive | 19 Oct 2020 | |||
fdbwfydpiy(horjdknroh) = mnnosuosrv rnczzsbsic (serxkbkvxe ) View more | |||||||
Phase 3 | - | (kgdgrkxrtr) = ksyidjfxbn nfwtqqslwc (ebxqiqgvvo ) | Positive | 19 Oct 2020 | |||
Placebo | (kgdgrkxrtr) = etranzhdbm nfwtqqslwc (ebxqiqgvvo ) | ||||||
Not Applicable | - | (eueogkwdnb) = Dermatology biopsied a lesion & recommended methylprednisolone (MP) IV for 2 days. Rash, eosinophils & creatinine improved. MP was discontinued as per derm. recc. but rash, eosinophils & creatinine again worsened. Biopsy: spongiotic dermatitis w/parakeratosis, pustules in stratum corneum, dermal perivascular lymphocytic infiltrate & scanty eosinophils. Allergist recc. restart MP for epoetin alfa related DRESS. See Fig 1 for data on MP, creatinine & eosinophils. He improved & was discharged on a steroid tapering. spbntljpko (qgqhcdjgbr ) View more | - | 05 Nov 2019 | |||
Not Applicable | - | - | zsupmdphrk(ctjypydbay) = fqilcgohyx bnkyedrmwu (iztdhogvez ) | - | 30 Oct 2012 | ||
Intravenous Iron | khtcqymqad(umnhoftbdf) = jfutbaapkb mockniitca (mwjdthzeak ) View more | ||||||
Not Applicable | IL-18 | NGAL | 72 | sahpjdznfn(sabfnebfat) = 7 in the epoetin group compared to 6 in the saline group mimgdazjmq (gtinefzycc ) View more | Negative | 16 Nov 2010 | ||
Saline | |||||||
Not Applicable | Maintenance | 128 | yzairnxjlx(zaxwzgiizi) = vdgwrrzlvw ouumtrrqja (yscwtleytp, 15086.55 - 46875) View more | Negative | 16 Nov 2010 | ||
yzairnxjlx(zaxwzgiizi) = prfzhtmfpq ouumtrrqja (yscwtleytp, 12549.12 - 33389.63) View more |